The National Agency for Food and Drug Administration and Control has alerted Nigerians to the recall of MR.7 SUPER 700000 capsules, a product marketed online as a dietary supplement for male enhancement.
This was disclosed in a public notice issued by the agency.
According to the regulator, the manufacturer, StuffbyNainax LLC, is voluntarily recalling all available lots of the product after an analysis found the capsules contained undeclared pharmaceutical ingredients.
What NAFDAC said
According to the agency, the recall followed an analysis which found that MR.7 SUPER 700000 capsules contained sildenafil and tadalafil, substances commonly used in prescription medicines for the treatment of erectile dysfunction.
- “The recall follows an FDA analysis, which found “MR.7 SUPER 700000’’ capsules to contain undeclared ingredients (tadalafil and sildenafil). Sildenafil and tadalafil are phosphodiesterase (PDE-5) inhibitors found in FDA-approved products for the treatment of male erectile dysfunction
- “The presence of sildenafil and tadalafil in “MR.7 SUPER 700000’’ capsules renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall,” they stated.
NAFDAC explained that the presence of these substances makes the capsules unapproved drugs, since the product is marketed as a dietary supplement and its safety and efficacy have not been established.
- “Consumption of products containing undeclared sildenafil or tadalafil may cause serious health risks,” the agency stated.
More details
NAFDAC noted that the substances may interact with nitrates used in certain prescription medicines, such as nitroglycerin, which are commonly prescribed for heart conditions.
The interaction could result in a dangerous drop in blood pressure, which may be life-threatening.
According to the agency, individuals with diabetes, high blood pressure, high cholesterol, or heart disease are particularly vulnerable because they often take nitrate-based medications
The agency provided the following details about the recalled product:
- Product name: MR.7 SUPER 700000
- Manufacturer: StuffbyNainax LLC
- Batch number: All available lots
- Product form: Capsules
- Product description: Dietary supplement marketed for male enhancement
NAFDAC urged members of the public who have the product to stop selling or using it immediately and return it to the nearest NAFDAC office.
Consumers were also encouraged to report compromised medicines or medical devices to the nearest NAFDAC office, through the agency’s toll-free line 0800-162-3322, or via email at sf.alert@nafdac.gov.ng
What you should know
NAFDAC recently alerted Nigerians to a Notice of Concern issued by the World Health Organization’s Prequalification Service over four NAFDAC-registered diagnostic kits manufactured by Meril Diagnostics Pvt. Ltd in India after violations were identified during an audit of the company’s manufacturing facility.
The agency said that although the products were registered, they have not been imported into Nigeria and warned that if any of the devices are found in circulation in the country would be considered falsified and fraudulently imported.
- In another safety alert, NAFDAC recently directed the immediate withdrawal of multi-dose Artemether/Lumefantrine dry powder for oral suspension still in circulation across the country.
- The agency also flagged a suspected revalidated SMA Gold infant formula discovered in Kaduna State after altered expiry dates were linked to illness in a four-month-old infant.
Another is on the circulation of falsified Dostinex 0.5mg tablets in Nigeria. The legitimate product is registered but not yet imported, while the fake batches, GG3470, LG8659, and GG2440 have no NAFDAC registration and may be unsafe.
